A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects

What Was Tested

This registered phase 1 trial tested Liraglutide.

Participants will receive all three test substances.

The order of trial administration will be allocated by chance.

It had six arms (groups): IDeglira-IDeg-Liraglutide (experimental), IDeglira-Liraglutide-IDeg (experimental), IDeg-Liraglutide-IDeglira (experimental), IDeg-IDeglira-Liraglutide (experimental) and Liraglutide-IDeg-IDeglira (experimental).

Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide.

Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec.

Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male and female Chinese subjects, who are considered to be generally healthy, based on assessment of medical history, physical examination, and clinical laboratory data, as judged by the investigator. Age between 18 to 45 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 19.0 and 24.0 kg/sqm (both inclusive). Body weight at least 50.0 kg.

The full record lists 5 inclusion and 4 exclusion criteria.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-09-29 with completion listed for 2018-01-02.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum insulin degludec concentration time curve. Area under the plasma liraglutide concentration time curve.

It also tracked 11 secondary outcomes, for example Maximum observed serum insulin degludec concentration, Time to maximum serum insulin degludec concentration, Terminal elimination half-life for insulin degludec, Maximum observed plasma liraglutide concentration, Time to maximum plasma liraglutide concentration and Terminal elimination half-life of liraglutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.